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U.S. Department of Health and Human Services

Animal & Veterinary

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Leveraging Examples – Part IV: Food Safety Cooperative Agreements

by David B. Batson, Ph.D.
FDA Veterinarian Newsletter March/April 2003 Volume XVIII, No 2


This is the fourth in a series of articles on leveraging activities in the Center for Veterinary Medicine (CVM). Through the use of a real-life example of a cooperative agreement, this article will describe the cooperative agreement award process and will demonstrate how these agreements can be used as a leveraging tool for addressing important research questions posed by the Center.

A cooperative agreement serves as a mechanism through which collaboration can be established between the FDA and an institution or organization outside FDA. In so doing, substantial technical expertise is contributed by both parties. The FDA provides at least part of the funding for the project.

The FDA initiates the cooperative agreement process by publishing a Request for Application (RFA) in the Federal Register. The Grants Management and Program Staff reviews all applications for their responsiveness to the RFA. Those applications found to be non-compliant with the RFA are returned to the applicant without further consideration. An ad hoc panel of experts subsequently reviews applications that are in compliance with the RFA, determining the application’s scientific and technical merit. A National Advisory Council provides a second level of review on the scientific merit of the applications. Ultimately, the Director of the Center renders the final judgement regarding FDA funding decisions for that Center.

The responsiveness of cooperative agreement applications is based on the following criteria:

  1. Research should be proposed that is within one or more of the objectives listed in the Research Goals and Objectives Section.
  2. The proposed study is within the designated budget guideline and costs are adequately justified and fully documented;
  3. The rationale for the proposed study is sound and the study design is appropriate to address the objectives of the RFA;
  4. Laboratory and associated animal facilities are available and adequate;
  5. Support services, e.g., biostatistical, computer, etc. are available and adequate, and;
  6. The Principal Investigator and support staff have research experience, training and competence.

Once the agreement is awarded, substantive involvement continues in the research program, including, but not limited to the following:

  1. FDA appoints a Project Officer who actively monitors the supported program under each award. This includes annual site visits and the review of quarterly progress reports.
  2. FDA establishes a Project Advisory Group that provides guidance and direction to the Project Officer with regard to protocol development, data analysis and analytical methods used by the investigator.
  3. FDA scientists collaborate with the recipient and have final approval on experimental protocols, data analysis, interpretation of findings, and co authorship of publications.

A Sample Cooperative Agreement Program: Microbial Hazards Associated with the Animal Production Environment

FDA is mandated to assure the microbiological safety of foods, including those derived from animals. Even though the American food supply is among the safest in the world, millions of Americans are stricken yearly by illnesses caused by the food they consume. Some 5,000 people per year, primarily the very young and elderly, die as a result of these foodborne illnesses. One of the goals of the Agency’s Food Safety Research Program is to reduce the incidence of foodborne disease to the greatest extent possible through the recognition of appropriate prevention procedures. CVM’s concerns relate to microbial hazards associated with the pre-harvest phases of food animal production, including aquaculture.

In order to address some of the questions associated with the microbial hazards pre-harvest research question, the Center launched a cooperative agreement program with the publication of an RFA. The specific program objective was to stimulate research on microbiological hazards associated with the food animal production environment. It was of particular interest to FDA that this research advance scientific knowledge of human foodborne pathogens, such as Salmonella, Escherichia coli, and Campylobacter. Potential areas of investigation included: (1) selection for and dissemination of antimicrobial resistance in the animal production environment, (2) approaches to mitigate or minimize antimicrobial resistance, and (3) the impact of antimicrobial drug use on the carriage of foodborne pathogens and sentinel microorganisms used for monitoring programs.

Projects that fulfilled any one or a combination of the following specific objectives were considered for funding:

  1. Studies on the development, dissemination, transmission and persistence of antibiotic resistant bacteria and/or genetic determinants from these bacteria in the animal production environment. The horizontal transmission of antimicrobial resistant bacteria and resistance genes in the animal and animal production environment was of special interest. Also, the persistence of antimicrobial resistant foodborne pathogens and/or genes in the animal production environment after withdrawal of antimicrobials was of special interest. FDA/CVM was interested in research in all food-producing animal species, but was especially interested in poultry and the poultry production environment.
  2. Research on the mitigation/intervention strategies to decrease or minimize antimicrobial resistance in the animal production environment through the manipulation of drug use, altering drug dosages (including amount, frequency and duration of drug administration), use of competitive exclusion products, and/or the rotation of antimicrobials administered to beef cattle, dairy cattle, swine, poultry, and aquaculture species.
  3. The effect of antimicrobial use on the carriage and/or shedding of foodborne pathogens (i.e., pathogen load) in the above listed animal species.

This program allowed the Center to leverage and expand its on-going program by partnering with outside organizations, such as, universities. This collaboration permitted the Center to utilize outside microbiological expertise, facilities, and equipment to address significant research questions on microbial hazards associated with pre-harvest phases of food animal production. Additional information on the projects that were funded under this program can be found on CVM’s web.

Concluding Comments

Although this particular cooperative agreement program was initiated by the FDA, it is possible for individuals and organizations to submit proposals based upon projects consistent with the mission of CVM. Therefore, if you have any questions on the Food Safety Cooperative Agreement Program, leveraging in general, or if you have an interest in initiating a collaboration with CVM, please contact Dr. David Batson at 301- 827-8021 or David Lynch at 301-827-5337.

Dr. Batson is a Health Science Administrator at CVM’s Office of Research.